Primary Objective is to compare the effect of different exercise protocols on intestinal permeability and on plasma levels of glutamine and glutamine-derived amino acids, in healthy young men. A Secondary Objective is to assess the effect of…
ID
Source
Brief title
Condition
- Gastrointestinal conditions NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are the relative increase in intestinal permeability
(lactulose/rhamnose ratio) and plasma levels of glutamine and glutamine-derived
amino acids.
Secondary outcome
As secondary endpoints several markers of gastro-intestinal integrity and
inflammation are studied in blood, urine and saliva.
Background summary
It is widely accepted that moderate to intense continuous exercise increases
intestinal permeability and leads to inflammatory responses. It is however
unknown which intensity is necessary to induce these effects. In order to
develop a commonly accepted and standardized physical stress model that can be
applied to a broad population, the current study will compare three exercise
protocols of different intensity. Furthermore, the role of proper hydration is
not well documented to date. Therefore we also investigate the effect of
hydration on intestinal permeability. We hypothesize that all exercise
protocols will lead to an increase in intestinal permeability and inflammatory
response. We further hypothesize that proper hydration can at least partially
prevent the increase in intestinal permeability
Study objective
Primary Objective is to compare the effect of different exercise protocols on
intestinal permeability and on plasma levels of glutamine and glutamine-derived
amino acids, in healthy young men. A Secondary Objective is to assess the
effect of different exercise protocols on immune - and gut barrier function
markers and inflammation in plasma, urine and saliva, in order to establish
reference values of relevant biomarkers of intestinal permeability and
inflammation in healthy young men. Fainally, we will establish the effect of
proper hydration on gastro-intestinal permeability during intense exercise.
Study design
Randomized cross-over trial with 5 different conditions: rest; 60 minutes
cycling at 70% of Wmax in euhydrated and dehydrated state; 60 minutes cycling
at 50% of Wmax ; 60 min intermittent cycling at 85% and 55% of Wmax
Intervention
Ingestion of multi sugar and glutamine- alanine solutions to evaluate gut
function. 5 different exercise conditions as described in study design
Study burden and risks
The risks for the subjects related to this study are minor. The exercise that
has to be performed is moderate to intense and will be well tolerated within
this group of participants, i.e. recreationally trained athletes. There is a
small risk of bruising regarding the blood sampling procedures. The ingestion
of the test products is not associated with an additional risk, and is well
tolerated. There is no direct health benefit for the subjects, but the
measurement of the Wmax and VO2max can be of interest for this group subjects.
Next to this, subjects completing the study will receive a financial
compensation of 75 ¤ for each experimental condition, i.e. 375 ¤ if they
complete the study. Blood, urine, and saliva will be collected at several time
points of the study. Next to this, the subjects have to adhere to specific
guidelines the last days before and during each experimental test day and
furthermore they will keep a log on diet, illness and exercise during the whole
experiment.
Bomenweg 2
6700 EV Wageningen 6703 HD
NL
Bomenweg 2
6700 EV Wageningen 6703 HD
NL
Listed location countries
Age
Inclusion criteria
• Male
• Generally healthy
• Recreational athlete with at least two years of cycling experience of at least twice a week
• 18-35 years old
• Meeting criteria of valid max-test
• Body mass index (BMI) 20-25 kg/m2
• Veins suitable for blood sampling at inspection
Exclusion criteria
• Known symptoms of immune diseases such as diabetes, celiac disease, gastric disease or cystic fibrosis
• Known symptoms of intestinal diseases such as Crohn*s disease, ulcerosis, irritable bowel syndrome or cystic fibrosis
• Smoking
• Use of hard drugs
• Use of specific medicines:
o Chronic use of NSAIDs: aspirin, ibuprofen, etc.
o Drugs for gastric and/or intestinal function
• Participation in other scientific studies
• Blood donation during the last six weeks prior to the start of the study
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL49412.081.14 |